Effect Of XP Endo Finisher Versus Ultrasonic Activated Irrigation On Post-operative Pain In Endodontic Treatment of Symptomatic Irreversible Pulpitis

NCT ID: NCT03096587

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2018-04-30

Brief Summary

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Recruited patients with symptomatic irreversible pulpitis are assigned to interventional (XP Endo Finisher file) and control group(ultrasonic activated irrigation) to undergo single visit endodontic treatment and record postoperative pain afterwards.

Detailed Description

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The investigator will recruit patients from the clinic of endodontics in faculty of oral and dental medicine, Cairo university.

The patients who are found eligible to the criteria, will be randomly assigned to either the control group (ultrasonic activated irrigation )or to the intervention group( XP Endo-Finisher file). Endodontic treatment will be done in single visit.

After the visit, patients will be asked to record post operative pain by NRS (Numerical Rate Scale)in a given sheet.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patient will be blinded and will not know the group he is in.

Study Groups

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XP Endo Finisher file

XP Endo Finisher file is used to activate irrigation as a final step in irrigation protocol

Group Type EXPERIMENTAL

XP Endo Finisher

Intervention Type DEVICE

a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature

ultrasonic activated irrigation

ultrasonic activated irrigation as a final step in irrigation protocol

Group Type ACTIVE_COMPARATOR

ultrasonic activated irrigation

Intervention Type DEVICE

by Satelec,Acteon, France

Interventions

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XP Endo Finisher

a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature

Intervention Type DEVICE

ultrasonic activated irrigation

by Satelec,Acteon, France

Intervention Type DEVICE

Other Intervention Names

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Irrisafe

Eligibility Criteria

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Inclusion Criteria

1. Medically- free of any systemic disease
2. Male or female
3. Patients with age range 25-45
4. Symptomatic irreversible pulpitis in single rooted single canal teeth without apical periodontitis.
5. Teeth with mature root
6. Restorable teeth
7. Teeth without calcified root canals
8. Teeth without root caries
9. Teeth without internal or external root resorption
10. Teeth with no sign of crack formation
11. Teeth without anatomic abnormalities

Exclusion Criteria

1. Pregnant females.
2. If analgesics have been administrated during the past two weeks preoperatively.
3. Patients having bruxism or clenching.
4. Multi rooted or multi canaled teeth.
5. Patients with swelling or acute peri-apical abscess.
6. Previously endodontically treated teeth
7. periodontally affected teeth .
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nouran Ahmed Hany Asal

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nouran A Hany, BDS

Role: PRINCIPAL_INVESTIGATOR

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Shaimaa I Gawdat, PHD

Role: STUDY_DIRECTOR

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Hebatallah M El-Far, Professor

Role: STUDY_CHAIR

Department of endodontics -Faculty of Oral and Dental Medicine-Cairo university

Locations

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Faculty of Oral and dental medicine, Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nouran A Hany, BDS

Role: CONTACT

+2 01223626996

Shaimaa I Gawdat, PHD

Role: CONTACT

+2 01222235502

Facility Contacts

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Nouran A Hany, BDS

Role: primary

+2 01223626996

References

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Alves FR, Andrade-Junior CV, Marceliano-Alves MF, Perez AR, Rocas IN, Versiani MA, Sousa-Neto MD, Provenzano JC, Siqueira JF Jr. Adjunctive Steps for Disinfection of the Mandibular Molar Root Canal System: A Correlative Bacteriologic, Micro-Computed Tomography, and Cryopulverization Approach. J Endod. 2016 Nov;42(11):1667-1672. doi: 10.1016/j.joen.2016.08.003. Epub 2016 Sep 15.

Reference Type RESULT
PMID: 27641947 (View on PubMed)

Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.

Reference Type RESULT
PMID: 27248848 (View on PubMed)

Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.

Reference Type RESULT
PMID: 25598754 (View on PubMed)

Other Identifiers

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CEBC-CU-2017-03-19

Identifier Type: -

Identifier Source: org_study_id

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